Syringe systems and methods for multi-stage fluid delivery

ABSTRACT

Embodiments of a syringe-based device for delivering fluid include a housing, a port, the port being positioned at about the distal end of the housing, a plunger assembly, the plunger assembly including, a plunger seal, a valve, and a cannula, a first fluid reservoir, where the first fluid reservoir retains a first type of fluid, a syringe including a syringe body, a syringe port, a plunger, and a second fluid reservoir, the second fluid retaining a second type of fluid, and where the syringe transitions from a first configuration in which a first portion of the first fluid type is delivered through the port, to a second configuration in which the second type of fluid in the second fluid reservoir is delivered through the port, to a third configuration in which a second portion of the first fluid type is delivered through the port.

REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. non-provisional applicationSer. No. 15/624,593, filed Jun. 15, 2017, which claims priority to U.S.Provisional Patent Application No. 62/350,341, filed Jun. 15, 2016,which are incorporated by reference herein in their entirety.

TECHNICAL FIELD

Embodiments of the technology relate, in general, to syringe technology,and in particular to syringe systems for the delivery of a medicamentfollowed by the delivery of a saline flush.

BACKGROUND

Supraventricular tachycardia (SVT) is a series of rapid heartbeats thatbegin in or involve the upper chambers (atria) of the heart. SVT cancause the heart to beat very rapidly or erratically. As a result, theheart may beat inefficiently, and the body may receive an inadequateblood supply. In controlled studies in the United States, bolus doses of3, 6, 9, and 12 mg of adenosine were studied to determine theeffectiveness of the medication on converting SVT to normal sinusrhythm. A cumulative 60% of patients with SVT converted to normal sinusrhythm within one minute after an intravenous bolus dose of 6 mgadenosine, and a cumulative 92% converted after a bolus dose of 12 mg ofadenosine. Adenosine slows conduction time through the A-V node, caninterrupt the reentry pathways through the A-V node, and can restorenormal sinus rhythm in patients with SVT, including SVT associated withWolff-Parkinson-White Syndrome. Intravenously administered adenosine israpidly cleared from the circulation via cellular uptake, primarily byerythrocytes and vascular endothelial cells. Adenosine has a half-lifeof less than 10 seconds in whole blood.

Adenosine injections are generally given as a rapid bolus via aperipheral I.V. route. The bolus dose is then generally followed with arapid saline flush to facilitate urging the adenosine towards thepatient's heart before degrading due to the short half-life. Therecommended doses for adults are 6 mg given as a rapid I.V. bolus,administered over a 1-2 second period, followed by a 12 mg bolus dose ofadenosine if the first dose does not result in elimination of the SVT in1-2 minutes. The 12 mg dose can be repeated a second time if required.The recommended neonatal dose is 0.05-0.1 mg/kg, followed by increaseddoses in 0.05-0.1 mg/kg increments every 1-2 minutes until terminationof the SVT. In adults, the bolus adenosine dose is generally followedwith a 20 ml saline flush and, for neonatal applications, the dose isgenerally followed by a 5-10 ml saline flush.

Current systems for delivering first the adenosine dose and then thesaline flush include the use of two syringes connected to a T-connectoror stopcock. A stopcock is attached to a capped I.V. line with anadenosine syringe on one port and a saline syringe (e.g., 10 ml) on asecond open port. The adenosine is then administered over 1-2 seconds,the stopcock is adjusted to access the second syringe, and the salineflush is then delivered to the patient. Such systems can havelimitations because of the time needed to transition the T-connector orstopcock from the first syringe to the second syringe. Because thehalf-life of adenosine is so rapid (i.e., less than 10 seconds), evensmall amounts of time lost can make a significant difference whether thepatient is able to return to a normal sinus rhythm. There are alsofrequent user errors associated with the stopcock or T-connectorsystems. If the wrong syringe is initially depressed, the full amount isnot administered from one or both syringes, the stopcock is not fullyadjusted to transition to the second syringe, or a variety of otherissues occur, the consequences for the patient can be severe. Thecurrent system also involves a relatively large number of steps to setup and deliver, where improved time efficiency and reduced steps may beadvantageous.

Adenosine is described by way of example, where numerous othermedications and biologics, such as epinephrine, are delivered in asimilar manner. Such other medications frequently have a short-halflife, can result in life-threatening consequences if administeredimproperly, and/or can be inoperative if improperly administered.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure will be more readily understood from a detaileddescription of some example embodiments taken in conjunction with thefollowing figures:

FIG. 1 is a schematic illustration of a syringe-based delivery deviceaccording to one embodiment;

FIG. 2 depicts a perspective view of a partially transparentsyringe-based delivery device having a distal reservoir for a medicamentand a proximal reservoir for a flush fluid according to one embodiment;

FIG. 3 depicts an exploded view of the syringe-based delivery deviceshown in FIG. 2;

FIG. 4 depicts a cross-sectional view of the syringe-based deliverydevice of FIG. 2 taken along reference line A-A and shown in a pre-useconfiguration;

FIG. 5 depicts a cross-sectional view of the syringe-based deliverydevice of FIG. 2, shown with a plunger depressed to expel the medicamentfrom the distal reservoir;

FIG. 6 depicts a cross-sectional view of the syringe-based deliverydevice of FIG. 2, shown with the plunger depressed to expel the flushfluid from the proximal reservoir.

FIG. 7 depicts a perspective view of a syringe-based delivery devicehaving finger pads on a syringe portion according to an alternateembodiment.

FIG. 8A depicts a perspective view of a syringe-based delivery devicehaving a locking mechanism according to one embodiment shown in a firstposition.

FIG. 8B depicts a perspective view of the syringe-based delivery deviceof FIG. 8, shown in a second position.

FIG. 8C depicts a perspective view of the syringe-based delivery deviceof FIG. 8, shown in a third position

FIG. 9 depicts a flow chart showing a method of operating asyringe-based delivery device according to one embodiment.

FIG. 10 depicts a flow chart showing a method of operating asyringe-based delivery device according to one embodiment.

FIG. 11 depicts a perspective view of a syringe-based delivery deviceaccording to an alternate embodiment.

FIG. 12 depicts an exploded view of the syringe-based delivery device ofFIG. 11.

FIG. 13 depicts a cross-sectional view of the syringe-based deliverydevice of FIG. 11 taken along reference line B-B and shown in a pre-useconfiguration.

FIG. 14 depicts a cross-sectional view of the syringe-based deliverydevice of FIG. 2, shown with a plunger urged proximally to draw amedicament into a distal reservoir;

FIG. 15 depicts a cross-sectional view of the syringe-based deliverydevice of FIG. 2, shown with the plunger depressed to expel themedicament from the distal reservoir;

FIG. 16 depicts a cross-sectional view of the syringe-based deliverydevice of FIG. 2, shown with the plunger depressed to expel the flushfluid from the proximal reservoir.

FIG. 17 depicts a perspective view of a syringe-based delivery deviceaccording to an alternate embodiment.

FIG. 18 depicts an exploded view of the syringe-based delivery deviceshown in FIG. 17.

FIG. 19 depicts a cross-sectional view of the syringe-based deliverydevice of FIG. 17 taken along reference line C-C and shown in a pre-useconfiguration.

FIG. 20 depicts a cross-sectional view of the syringe-based deliverydevice of FIG. 17, shown with a plunger urged distally to urge a firstamount of fluid from a first fluid reservoir;

FIG. 21 depicts a cross-sectional view of the syringe-based deliverydevice of FIG. 17, shown with the plunger removed and a syringe attachedhaving a second fluid reservoir;

FIG. 22 depicts a cross-sectional view of the syringe-based deliverydevice of FIG. 17, shown with a plunger of the syringe actuated distallyto expel fluid from the second reservoir.

FIG. 23 depicts a cross-sectional view of the syringe-based deliverydevice of FIG. 17, shown with the syringe urged distally to urge asecond amount of fluid from the first fluid reservoir;

FIG. 24 depicts a perspective view of a syringe-based delivery deviceaccording to an alternate embodiment.

FIG. 25 depicts an exploded view of the syringe-based delivery deviceshown in FIG. 24.

FIG. 26 depicts a cross-sectional view of the syringe-based deliverydevice of FIG. 24 taken along reference line D-D and shown in a pre-useconfiguration.

FIG. 27 depicts a cross-sectional view of the syringe-based deliverydevice of FIG. 24, shown with a seal removed from a housing of thedelivery device.

FIG. 28 depicts a cross-sectional view of the syringe-based deliverydevice of FIG. 24, shown with an actuator mechanism coupled with thehousing of the delivery device;

FIG. 29 depicts a cross-sectional view of the syringe-based deliverydevice of FIG. 24, shown with actuator mechanism moved distally to urgea first amount of fluid from a first fluid reservoir;

FIG. 30 depicts a cross-sectional view of the syringe-based deliverydevice of FIG. 24, shown with a plunger of actuator mechanism actuateddistally to expel fluid from the second reservoir.

FIG. 31 depicts a cross-sectional view of the syringe-based deliverydevice of FIG. 24, shown with the actuator mechanism urged distally tourge a second amount of fluid from the first fluid reservoir.

FIG. 32 depicts an exploded view of a syringe-based delivery deviceaccording to an alternate embodiment.

DETAILED DESCRIPTION

Various non-limiting embodiments of the present disclosure will now bedescribed to provide an overall understanding of the principles of thestructure, function, and use of the apparatuses, systems, methods, andprocesses disclosed herein. One or more examples of these non-limitingembodiments are illustrated in the accompanying drawings. Those ofordinary skill in the art will understand that systems and methodsspecifically described herein and illustrated in the accompanyingdrawings are non-limiting embodiments. The features illustrated ordescribed in connection with one non-limiting embodiment may be combinedwith the features of other non-limiting embodiments. Such modificationsand variations are intended to be included within the scope of thepresent disclosure. Although embodiments in the figures as illustratedare shown as transparent or semi-transparent, it will be appreciatedthat any suitable features can be opaque, colored, or the like.

Reference throughout the specification to “various embodiments,” “someembodiments,” “one embodiment,” “some example embodiments,” “one exampleembodiment,” or “an embodiment” means that a particular feature,structure, or characteristic described in connection with any embodimentis included in at least one embodiment. Thus, appearances of the phrases“in various embodiments,” “in some embodiments,” “in one embodiment,”“some example embodiments,” “one example embodiment,” or “in anembodiment” in places throughout the specification are not necessarilyall referring to the same embodiment. Furthermore, the particularfeatures, structures or characteristics may be combined in any suitablemanner in one or more embodiments.

Described herein are example embodiments of apparatuses, systems, andmethods for fluid delivery. In one example embodiment, a syringe-basedfluid delivery system or syringe-based device can be provided that candeliver a first fluid that can include a medicament or biologic. In someembodiments, the syringe-based fluid delivery system can include a fluidflush that can be delivered to a patient immediately after themedicament or biologic is delivered. In some embodiments, thesyringe-based fluid delivery system can include a pre-filled salineportion and a pre-filled medicament or biologic portion, where thesaline flush can be delivered immediately following the medicament orbiologic delivery. Embodiments of a syringe-based fluid delivery systemcan be configured to deliver a first portion of a flush fluid, deliver amedicament or biologic, and then deliver a second portion of a flushfluid. Some embodiments can include a syringe-based fluid deliverysystem that can be used to first draw a medicament or biologic into afirst reservoir, deliver the medicament or biologic to the patient, andthen administer a fluid flush. Embodiments of a syringe-based fluiddelivery system can be used to deliver epinephrine, adenosine, or anyother suitable fluid, component, drug, biologic or material. Embodimentsof the syringe-based fluid delivery system can deliver any suitableflush such as, for example, 10 ml of saline, 20 ml of saline, heparin,or the like.

Referring now to FIG. 1, a schematic illustration of a portion of asyringe-based transfer device 10 is shown according to an embodiment.Generally, the syringe-based transfer device 10 (also referred to hereinas “fluid transfer device,” “integrated flush device,” or “transferdevice”) can be designed or configured to facilitate the delivery offluid to a patient such that a first type of fluid to be delivered as amedicament or biologic is fluidically isolated from a second type offluid to be delivered as a fluid flush. The transfer device 10 can beconfigured to deliver a first, predetermined or selected amount of fluidfrom a first reservoir and a second amount of a different type of fluidfrom one or more reservoirs (e.g., fluid flush reservoirs) fluidicallyisolated from the first reservoir. Many drugs, such as adenosine, have arelatively short half-life (e.g., less than 10 seconds) and are used inpotentially life threatening situations such as, for example, when apatient is experiencing supraventricular tachycardia (SVT). SVT cancause the heart to bear very rapidly or erratically, which can result inthe heart beating inefficiently such that the body receives aninadequate blood supply. Delivery of a bolus amount of adenosine, suchas 3, 6, 9, or 12 mg, can result in a conversion from SVT to a normalsinus rhythm. For such a bolus administration to reach the patient'sheart it may be advantageous to provide, for example, a 20 ml salineflush as quickly as possible following the bolus adenosine delivery.Embodiments described herein may integrated the drug delivery (e.g.,adenosine) with the fluid flush (e.g., saline) into a single device suchthat the fluid flush is delivered immediately or substantiallyimmediately after delivery of the drug. In the illustrated example,adenosine can be provided in the first fluid reservoir 16 and the salinefluid flush can be provided in the second fluid reservoir 18. In analternate embodiment, epinephrine (e.g., 1 mg) can be provided in thefirst fluid reservoir 16 and a fluid flush (e.g., 20 ml saline) can beprovided in the second fluid reservoir 18.

The transfer device 10 can include a housing 12, an actuator mechanism14, a first fluid reservoir 16 (also referred to herein as “firstreservoir”, “medicament reservoir”, or “biologic reservoir”), and asecond fluid reservoir 18 (also referred to herein as “secondreservoir”, “fluid flush reservoir”, or “flush reservoir”), differentfrom the first reservoir 16. The housing 12 can be any suitable shape,size, or configuration and is described in further detail herein withrespect to specific embodiments. As shown in FIG. 1, the housing 12 caninclude a port 20 that can be at least temporarily physically andfluidically coupled to a medical device defining a pathway fordelivering the first and second fluids from the transfer device 10. Forexample, the port 20 can be a LUER-LOK or the like configured to bephysically and fluidically coupled to a peripheral intravenous line, aCentral Venous Catheter (CVC) line, a needle, a cannula, otherlumen-containing devices, or the like. In other embodiments, the port 20can be monolithically formed with at least a portion of thelumen-containing device.

In example embodiments, the port 20 can include a one-way valve suchthat fluid flow is unidirectional out of the transfer device 10 in thedirection shown by the arrows of FIG. 1. The one-way valve can bemonolithically formed with the port 20, fixedly coupled with the port20, or selectively coupled with the port 20. In certain embodiments, theone-way valve can be threadedly coupled with the port 20, attached witha press fit, or can be formed as a one piece, unitary construction withthe port 20. During use, the one-way valve can prevent fluid, such asfluid from a peripheral IV, from being accidentally drawn into the port20 and the transfer device 10.

As shown in FIG. 1, the housing 12 can define an inner volume 22 thatcan be configured to receive a portion of the actuator mechanism 14.More specifically, the actuator mechanism 14 can be at least partiallydisposed within the inner volume 22 defined by the housing 12 and can bemovable between a first configuration and a second configurationrelative to the housing 12. The housing 12 can also be configured todefine at least a portion of the first reservoir 16 as will be describedin more detail herein.

The first reservoir 16 can be at least partially defined by a set ofwalls of the housing 12 that define the inner volume 22. For example,the first reservoir 16 can be a cavity defined by the distal end orplunger of the actuator mechanism 14 and the housing 12, where theplunger and housing 12 can cooperate to form a substantially fluidicallysealed chamber. The first reservoir 16 can have a variable volume, whereurging or drawing the actuator mechanism 14 proximally such as, forexample, when the transfer device 10 is being pre-filled, cancorrespondingly increase the volume of the first reservoir 16. A portionof the piston or plunger can form a substantially fluid tight seal withthe walls of the housing 12 defining the inner volume 22. In thismanner, the housing 12 and the actuator mechanism 14 can collectivelyform a sealed, air-tight cavity (e.g., a syringe) such that the actuatormechanism 14 (or at least a portion of the actuator mechanism 14) canurge outward and expel fluid contained within the inner volume 22.

In certain embodiments, the second reservoir 18 can be housed within aportion of the actuator mechanism 14 and can be configured to retain anddispense any suitable fluid, such as a 10 ml or 20 ml saline flush. Thesecond reservoir 18 can be defined by any suitable structure orcombination of structures such as, for example, a syringe having aplunger and a threaded distal end that is selectively coupled with aone-way valve. The syringe can be used to expel fluid, such as a fluidflush, out of the second reservoir 18, where the syringe defining thesecond reservoir 18 can be selectively removable from the actuatormechanism 14 in one embodiment.

There are circumstances in which it may be advantageous to selectivelyattach the second reservoir 18 from the transfer device 10. For example,in neonatal applications it may be desirable to provide a lower volumeof saline flush (e.g., 5 ml) such that a smaller syringe and/or smallersecond reservoir 18 can be provided. Providing a selectively attachablesecond reservoir 18 in the form of a selectively attachable syringe canallow for any suitable volume or type of fluid to be coupled with thetransfer device 10 as needed. Any suitable mechanism to expel the fluidfrom the second reservoir 18 is contemplated where, for example, thesyringe can include a plunger that can be used to expel such fluid.

The actuator mechanism 14 can have any suitable shape, size, orconfiguration and can include any suitable number or type of components.For example, in some embodiments, the shape and size of at least aportion of the actuator mechanism 14, such as the outer portion, cansubstantially correspond to the shape and size of the walls of thehousing 12 defining the inner volume 22. As described above, at least aportion of the actuator mechanism 14 can be movably disposed within theinner volume 22 of the housing 12. For example, in some embodiments, adistal end portion of the actuator mechanism 14 can be disposed withinthe inner volume 22 of the housing 12 and a proximal end portion of theactuator mechanism 14 can be disposed substantially outside the housing12. In such embodiments, a user can engage the proximal end portion ofthe actuator mechanism 14 to move the portion of the actuator mechanism14 disposed within the inner volume 22 distally to expel fluid from thefirst reservoir 16.

In some embodiments, the actuator mechanism 14 can include a firstmember and a second member. The first member and the second member canbe collectively moved within the inner volume 22 of the housing 12. Inaddition, the first member and the second member can be configured tomove independently within the housing 12. Similarly stated, the firstmember can be moved relative to the second member and/or the secondmember can be moved relative the first member, as further describedherein with respect to specific embodiments. In some embodiments, thefirst member and/or the second member can form a piston or plungerconfigured to move within the inner volume 22. In one embodiment thefirst member is a fluid flush syringe and the second member cooperateswith the housing 12 to function as a second syringe. Such a system canbe described as a “dual syringe” system.

The second reservoir 18 can be any suitable reservoir for containing,for example, a fluid flush. For example, in some embodiments, the secondreservoir 18 can be defined by an internal syringe comprising the firstmember of the actuator mechanism 14. In some embodiments, the secondreservoir 18 can be a saline flush reservoir, but any suitable fluid,such as a second medication or biologic, is contemplated. The secondreservoir 18 can be selectively placed in fluid communication with thehousing 12 or the actuator mechanism 14. The second reservoir 18 and/orthe first member (e.g., a fluid flush syringe) can be selectivelyattachable from the actuator mechanism 14.

The first reservoir 16 can be any suitable reservoir and can beconfigured to receive and contain a first type and amount of fluid. Insome embodiments, the first reservoir 16 can be defined by a portion ofthe walls of the housing 12 defining the inner volume 22 and a portionof the actuator mechanism 14. In this manner, when the actuatormechanism 14 is in the first configuration, a portion of the actuatormechanism 14 and a portion of the housing 12 can define a first fluidflow path 24 to fluidically couple the port 20 to the first reservoir16. It will be appreciated the first and second fluid flow paths 24, 26,as described herein, can pass initially through the same lumen of theport 20. In an alternate embodiment, the first fluid flow path 24 canpass through a first port, and the second fluid path can pass through asecond port, where the first port and the second port can be fluidicallyisolated. In some embodiments, the movement of the actuator mechanism 14distally can be such that the distally applied force facilitates theflow of the fluid through the first fluid flow path 24 and out of thefirst reservoir 16. In certain embodiments, the first type and amount offluid can be an amount given to the patient subsequent to delivery ofthe second type and amount of fluid. In some embodiments, the firstreservoir 16 can contain the first type of fluid such that the firstamount and type is fluidically isolated from the second amount and typeof fluid.

The second reservoir 18 can be sized to receive and contain, forexample, a predetermined amount of a flush fluid. During use, the firstmember (e.g., a syringe) of the actuator mechanism 14 can define asecond fluid flow path 26 to fluidically couple the port 20 of thehousing 12 to the second reservoir 18. In some embodiments, a portion ofthe actuator mechanism 14, such as the plunger of the syringe, can beurged distally and can facilitate the distal flow of the flush fluidthrough the second fluid flow path 26 and out of the second reservoir18. The second reservoir 18 can be designed and sized to retain thefirst type of fluid such that the first type is fluidically isolatedfrom a second type of fluid (different from the first type of fluid)that is subsequently given to the patient.

In certain embodiments, the actuator mechanism 14 and the secondreservoir 18 can be sized and configured with a pre-set amount of fluidthat can be administered during a procedure. Such a pre-set embodimentmay be desirable when a consistent amount of fluid flush is given duringmost or all medicament or biologic delivery procedures. For example, theactuator mechanism 14 and second reservoir 18 can be size to retainabout 10 ml of fluid, about 20 ml of fluid, or any other suitable amountof fluid. In alternate embodiments, it may be desirable to provide auser-selectable volume of fluid to be provided in the second reservoir18. For example, in neonatal applications it may be desirable to provide5 ml or less of fluid, whereas for a larger adult it may be desirable todeliver from about 10 ml to about 20 ml of flush fluid. User selectable,variable volume embodiments are contemplated.

As described above, the transfer device 10 can be used to transfer afluid to a patient from the second reservoir 18 and/or first reservoir16 included in the transfer device 10. More specifically, the flow ofthe first amount of fluid transferred from the first reservoir 16 can beany suitable medicament, biologic, or the like such as, for example,adenosine, epinephrine, atropine, etomidate, rocuronium,succinylcholine, NARCAN, amiodarone, or the like. The first reservoir 16can fluidically isolate the first type of fluid such that when secondtype of fluid retained within the second fluid reservoir 18 does not mixwith the first type of fluid.

In some embodiments, the transfer device 10 can be configured such thatthe first type of fluid must be conveyed from the first reservoir 16through the first fluid flow path 24 before the transfer device 10 willpermit the flow of the second type of fluid through the second fluidflow path 26 from the second reservoir 18. In such embodiments, thetransfer device 10 can be characterized as requiring compliance by ahealth care practitioner regarding the delivery of the first,predetermined amount (e.g., 1 mg of epinephrine) prior to delivery ofthe second amount (e.g., a 20 ml saline flush) of fluid. Similarlystated, the transfer device 10 can be configured to prevent a healthcare practitioner from delivering the second fluid type, such as a fluidflush, fluid from the second reservoir 18 without first diverting thefirst type of fluid out of the first reservoir 16. In this manner, thehealth care practitioner can be prevented from delivering (whetherintentionally or unintentionally) the second type of fluid from thesecond reservoir 18 before delivering the first type of fluid from thefirst reservoir 16. For example, a clinician can be prevented fromadministering a saline flush before delivering a medicament or biologicto a patient.

FIGS. 2-6 illustrate a syringe-based transfer device 110 according to anembodiment. The syringe-based transfer device 110 (also referred toherein as “fluid transfer device,” “integrated flush device,” or “drugdelivery device”) includes a housing 112 and an actuator mechanism 114.The transfer device 110 can be configured to include or define a firstfluid reservoir 116 (also referred to herein as “first reservoir” or“medicament reservoir”) and a second fluid reservoir 118 (also referredto herein as “second reservoir” or “fluid flush reservoir”). Thetransfer device 110 can be any suitable shape, size, or configuration.For example, while shown in FIGS. 2 and 3 as being substantiallycylindrical, the transfer device 110 can be square, rectangular,polygonal, and/or any other non-cylindrical shape.

As shown in FIGS. 2 and 3, the housing 112 can include a proximal endportion 130 and a distal end portion 132 and can define an inner volume122 therebetween. In some embodiments, the housing 112 can besubstantially similar to a syringe body. The proximal end portion 130 ofthe housing 112 can be substantially open and can be configured toreceive at least a portion of the actuator mechanism 114 such that atleast the portion of the actuator mechanism 114 can be movably disposedwithin the inner volume 122. Furthermore, the inner volume 122 can beconfigured to define the first fluid reservoir 116, as further describedherein. The distal end portion 132 of the housing 112 can include a port120. In some embodiments, the port 120 can be monolithically formed withthe housing 112 (e.g., as shown in FIGS. 2 and 3). In other embodiments,the port 120 can be coupled to the distal end portion 132 in anysuitable manner such as, for example, via a friction fit, a threadedcoupling, a mechanical fastener, an adhesive, any number of matingrecesses, and/or any combination thereof.

The port 120 can be any suitable shape, size, or configuration. Forexample, in some embodiments, at least a portion of the port 120 canform a lock mechanism configured to be physically and fluidicallycoupled to a peripheral IV line, a Central Venous Catheter (CVC) line, aneedle, a cannula, or other lumen-containing device. For example, insome embodiments, the port 120 can be a LUER-LOK or similar lockingmechanism that can be configured to physically and fluidically couple toa CVC line (not shown). In other embodiments, the port 120 can bemonolithically formed in a unitary, one piece construction with at leasta portion of the lumen-containing device. In this manner, the port 120can be placed in fluid communication with a lumen defined by thelumen-defining device and to receive the bodily-fluid from a patientwhen the lumen-defining device is disposed within the patient.

The actuator mechanism 114 can be disposed within the inner volume 122and can be movable between a first position (e.g., a proximal positionrelative to the housing 112) and a second position (e.g., a distalposition relative to the housing 112). The movement of the actuatormechanism 114 relative to the housing 112 can move the transfer device110 between a number of different configurations and positions, asfurther described herein. The actuator mechanism 114 can include a firstmember 134 and a second member 136. The first member 134 of the actuatormechanism 114 can include a plunger 144 and a syringe body 138 that candefine an inner volume 142 therebetween. At least a portion of the innervolume 142 can be configured to define the second fluid reservoir 118,as further described herein. The plunger 144 can include a plunger seal140 that can fluidically seal the second fluid reservoir 118. Thesyringe body 138 can include an open proximal end such that the plunger144 can be movably disposed within the inner volume 142.

The distal end portion of the first member 134 can include an attachmentelement 152, such as a LUER-LOK or similar locking or couplingmechanism, that can be configured to selectively physically andfluidically couple the first member 134 with the second member 136. Theattachment element 152 can be threadedly engaged with the second member136 such that rotation of the first member 134 (e.g., 90 degrees in aclockwise direction) will disengage the first member 134 from the 136.The attachment element 152 can include a port which can, for example, besimilar in construction and operation to port 120 described herein. Itwill be appreciated that the attachment element 152 can be selectivelyattached and decoupled from the second member 136 in any suitable mannersuch as, for example, with a threaded engagement, a snap fit, andfriction fit, a user-accessible locking mechanism, or the like.

The second member 136 can include a plunger seal 154 that can form afriction fit with the inner surface of the walls defining the innervolume 122 when the actuator mechanism 114 is disposed within thehousing 112. Similarly stated, the plunger seal 154 can define a fluidicseal with the inner surface of the walls defining the inner volume 122such that a portion of the inner volume 122 distal of the plunger seal154 is fluidically isolated from a portion of the inner volume 122proximal of the plunger seal 154. The plunger seal 154 can define achannel 156 that that can extend through a distal end and a proximal endof the plunger seal 154. A portion of an inner set of walls defining thechannel 156 can accept a valve seat 158. In this manner, a portion ofthe channel 156 can receive a valve 160 that can be in contact with thevalve seat 158. The valve 160 can include a threaded proximal end 162 orthreaded proximal portion that can selectively engage the attachmentelement 152 of the first member 134 as described herein.

The valve 160 can be any suitable valve. For example, in someembodiments, the valve 160 can be a one-way check valve to allow a flowof a fluid from a proximal end of the valve 160 to a distal end of thevalve 160, but substantially not allow a flow of the fluid from thedistal end to the proximal end. The valve 160 can be disposed within thechannel 156 and can be in contact with the valve seat 158 such that thevalve 160 forms a substantially fluid tight seal with the walls definingthe channel 156. In some embodiments, the valve 160 can form a frictionfit with walls defining the channel 156. In other embodiments, the valve160 can form a threaded coupling or the like with at least a portion ofthe walls. The valve 160 can also include a seal member configured toengage the valve seat 158 to form at least a portion of the fluid tightseal.

As described above, the second member 136 can be movably disposed withinthe housing 112. More specifically, the second member 136 can be movablebetween a first configuration (e.g., a proximal position) and a secondconfiguration (e.g., a distal position) to create positive pressure tourge for example, a medicament, out of the first fluid reservoir 116. Afirst coefficient of friction between the plunger seal 140 and thesyringe body 128 can be greater than a second coefficient of frictionbetween the plunger seal 154 and the housing 112. In this manner, thedistal translation of the plunger 144 can first cause the plunger seal154 to move distally to expel the fluid from the first fluid reservoir116. Once the first fluid reservoir 116 has been emptied through theport 120, where the plunger seal 154 may now be seated at the aboutdistal end portion 132 of the housing, continued distal movement of theplunger 133 can result in distal movement of the plunger seal 140 suchthat the fluid retained within the second fluid reservoir 118 isexpelled out of the syringe body 128 and through the port 120. Inembodiments where relying upon the difference in the coefficients offriction between the plunger seal 140 and the plunger seal 154 alone isinsufficient, an annular catch 171 can be provided on the syringe body138 that can engage a portion 173 of the plunger seal 140 that canextend radially outward. The annular catch 171 and the portion 173 cancooperate in an interference fit, where the annular catch 171 and theportion 173 can be sized and otherwise configured to require a thresholdof force to overcome the interference fit that is greater than the forcerequired to advance the plunger seal 154 distally. It will beappreciated that the syringe body 138, the plunger seal 140, and/or anyother components can be modified to prevent the second fluid reservoir118 from being expelled before the first fluid reservoir 116 isexpelled.

In use, a user can engage the transfer device 110 to couple the port 120to a proximal end portion of a lumen-defining device (not shown) suchas, for example, a CVC line, a PICC line, a butterfly needle, a cannulaassembly, a trocar, or the like. With the port 120 physically coupled tothe lumen-defining device, the port 120 can be placed in fluidcommunication with the lumen defined by the lumen-defining device. Thedistal end portion of the lumen-defining device can be disposed within aportion of the body of a patient (e.g., a vein). In this manner, theport 120 can be placed in fluid communication with the portion of thebody.

With the port 120 coupled to the lumen-defining device, a user (e.g., aphlebotomist, a nurse, a technician, a physician, or the like) can movethe transfer device 110 from a first configuration (FIG. 4) to a secondconfiguration (FIG. 5). More specifically, the user can depress anengagement portion 168 of the plunger 144 to move the plunger seal 154distally to create positive pressure within the first fluid reservoir116. As shown in FIG. 5, the positive pressure in the first fluidreservoir 116 can urge the fluid, such as a medicament or biologic,through the port 20 and into the patient. The plunger seal 154 can beurged in a distal direction relative to the housing 112 until theplunger seal is seated against the distal end portion 132 of thehousing.

In certain embodiments, the arrangement of the plunger 144 within thesyringe body 138 is such that the distal motion of the plunger 144 doesnot decrease or substantially decrease the inner volume 142 that isdistal of the plunger seal 140, which can contain the second fluidreservoir 118. With the plunger seal 140 forming a fluid tight seal withthe inner surface of the walls defining the inner volume 142, theincrease of pressure can first fully distally advance the plunger seal154 before the plunger seal 140 can move relative to the syringe body138.

As shown in FIG. 6, the transfer device can be transitioned from asecond configuration to a third configuration. The port 120, the valve160, the attachment element 152, and the channel 156 can define a fluidflow path that places the second fluid reservoir 118 in fluidcommunication with the lumen-defining device (not shown) connected tothe patient. Therefore, the second fluid reservoir 118 cancorrespondingly be placed in fluid communication with the portion of thepatient (e.g., the vein). The positive pressure within the second fluidreservoir 118 can be operative in moving the valve 160 from a closedconfiguration to an open configuration. In this manner, the positivepressure within the within the second fluid reservoir 118 that can beproduced by the movement of the plunger 144 can urge the fluid withinthe second fluid reservoir 118 out of the transfer device 10. Fluid canbe urged out of the second fluid reservoir 118, through the syringe body138, through the attachment element 152, through the valve 160, andthrough the port 20 into the patient. In some embodiments, the fluidexpelled from the second fluid reservoir 118 can be a fluid flush, suchas a 20 ml saline flush.

In some embodiments, the magnitude of the positive pressure can bemodulated by increasing or decreasing the amount of a force applied tothe plunger 144. For example, in some embodiments, it can be desirableto limit the amount of positive pressure introduced to a vein or througha line. In such embodiments, the user can reduce the amount of forceapplied to the engagement portion 168. In this manner, the rate ofchange (e.g., the decrease) in the volume of the first fluid reservoir116 can be sufficiently slow to allow time for the positive pressuredifferential between the vein and the fluid reservoir to come toequilibrium before further decreasing the volume of the first fluidreservoir 116. Thus, the magnitude of the positive pressure can bemodulated.

While in the third configuration, the transfer device 110 can beconfigured to transfer a desired amount (e.g., a predetermined amount ora user-selected amount) of fluid out of the second fluid reservoir 118.In some embodiments, the volume can substantially correspond to the sizeof the second fluid reservoir 118. In other embodiments, the volume canbe monitored and determined by the clinician as they depress the plunger144 distally. When distal pressure on the plunger 144 is alleviated thevalve 160 may be allowed to close.

The arrangement of the first member 134 and the second member 136 withinthe inner volume 122 of the housing 112 can be such that the proximalmotion of the first member 134 and second member 136 decreases thevolume of the portion of the inner volume 122 that is distal of theplunger seal 154, such that the first fluid reservoir 116 is emptiedbefore the second fluid reservoir 118 is emptied. With the plunger seal154 seated against the distal end portion 132 of the housing, thecontinued positive pressure in a distal direction applied to the plunger144 can then empty the second fluid reservoir 118.

In some embodiments, the volume of the first fluid reservoir 116 issufficient to contain a desirable amount of a medicament or biologic. Inother embodiments, the first fluid reservoir 116 can contain from about0.1 ml to about 3.0 ml. In still other embodiments, the first fluidreservoir 116 can contain from about 3.0 ml, 4.0 ml, 5.0 ml, 6.0 ml, 7.0ml, 8.0 ml, 9.0 ml, 10.0 ml, 15.0 ml, 20.0 ml, 25.0 ml, 50 ml, or anyvolume or fraction of volume therebetween. In one embodiment, thepressure within the first fluid reservoir 116 can be such that the forceapplied to the plunger 144 does not substantially move the first member134 relative to the second member 136. In such examples, the forceapplied to the engagement portion 168 can collectively move the secondmember 136 and the first member 134 in the distal direction relative tothe housing 112 to expel the fluid from the first fluid reservoir 116into the lumen-defining device of the patient.

In alternate embodiment, as shown in FIG. 7, the syringe body 138 caninclude a pair of radial flanges 170 at about the distal end of thesyringe body, where the radial flanges 170 can be urged distally to movethe syringe body 138 relative to the housing 112, where such motion canexpel the fluid from the first fluid reservoir 116. Once the fluid hasbeen expelled from the first fluid reservoir 116, the plunger 144 cansubsequently be depressed to expel the fluid from the second fluidreservoir 118. The variance in the coefficient of friction between theplunger seal 140 and the plunger seal 154 may be sufficient to permitdistal actuation of the plunger 144 to expel the first fluid reservoir116 before expelling the second fluid reservoir 118. However, othermechanical features are contemplated, such as thumb pads to depress thesyringe body 138, where the plunger 144 may only need to be depressed toexpel fluid from the second fluid reservoir 118. It is furthercontemplated that the syringe body 138 and the plunger 144 can bemechanically coupled to prevent relative movement between the syringebody 138 and the plunger 144 until such a coupling is decoupled. Thecoupling can include a latch, pin, lock, clasp, or any other suitablecoupling that can temporarily limit relative movement between theplunger and the syringe body until it is desirably to expel from fluidfrom the second fluid reservoir 118.

FIGS. 8A-8C illustrate a perspective view of a transfer device 110having a locking mechanism 179 according to one embodiment. As describedabove, it may be desirable to prevent relative movement between theplunger 144 and the syringe body 138 until the fluid in the first fluidreservoir 116 has been fully dispensed. In addition to, or in place of,an interference fit between the annular catch 171 and the portion 173 ofthe plunger seal 140, the transfer device can include the lockingmechanism 179. The locking mechanism 179 can include a radial projection180 that can be pivotable radially outward about a pin 182. In a firstlocked position (FIGS. 8A and 8B), the radial projection can be pivotedoutward such that it is substantially perpendicular to the axis ofmotion of the plunger 144. The radial projection 180 can define a cutoutor stop 184 that can engage the proximal surface 181 of the syringe body138. As shown in FIG. 8B, in the closed position, the locking mechanism179 will result in distal movement of the plunger 144 correspondinglymoving the syringe body 138 in the distal direction. In this manner thelocking mechanism 179 can help insure that the fluid in the first fluidreservoir 116 is expelled before the fluid in the second fluid reservoir118 is expelled.

As shown in FIG. 8C, after the plunger 144 has been depressed to expelthe fluid from the first fluid reservoir 116, the radial projection 180can be pivoted, for example, about 90 degrees, such that the radialprojection 180 is substantially parallel to the axis of motion of theplunger 144. In this “open” position, as illustrated, the radialprojection 180 does not interfere with the proximal surface 181 of thesyringe body 138, where the radial projection 180 can now pass withinthe syringe body 138. In use, after the fluid has been dispensed fromthe first fluid reservoir 116, the locking mechanism 179 can be “opened”or transitioned to the second position such that the plunger 144 can bedepressed to expel fluid from the second fluid reservoir 118.

FIG. 9 illustrates a flow chart depicting a Method 1000 for using afluid transfer device, such as fluid transfer device 110. Method 1000can include Providing a Fluid Delivery Device 1002, which can includeproviding any suitable fluid transfer device. Method 1000 can includeDelivering a First Fluid from a First Fluid Reservoir 1004, which caninclude dispensing a medicament or a biologic from the first fluidreservoir 116. Method 1000 can include Delivering a Second Fluid from aSecond Fluid Reservoir 1006, which can include dispensing a flush fluidfrom the second fluid reservoir 118.

FIG. 10 illustrates a flow chart depicting a Method 1100 for using afluid transfer device, such as fluid transfer device 310, 410, and 510,as described herein. Method 1100 can include Providing a Fluid DeliverySystem 1102. Method 1100 can include Delivering a First Amount of aFirst Fluid from a First Fluid Reservoir 1104, which can includedelivering a first amount of a saline flush. Method 1100 can includeDelivering a Second Fluid from a Second Fluid Reservoir 1106, which caninclude delivering a medicine with a syringe. Method 1100 can includeDelivering a Second Amount of the First Fluid from the First FluidReservoir 1108, which can include delivering a second amount of thesaline flush.

FIGS. 11-16 illustrate a syringe-based transfer device 210 according toan embodiment. The syringe-based transfer device 210 (also referred toherein as “fluid transfer device,” “integrated flush device,” or “drugdelivery device”) includes a housing 212 and an actuator mechanism 214.The transfer device 210 can be configured to define a first fluidreservoir 216 (also referred to herein as “first reservoir” or“medicament reservoir”) and a second fluid reservoir 218 (also referredto herein as “second reservoir” or “fluid flush reservoir”). Thetransfer device 210 can be any suitable shape, size, or configuration.For example, while shown in FIGS. 11 and 12 as being substantiallycylindrical, the transfer device 210 can be square, rectangular,polygonal, and/or any other non-cylindrical shape.

As shown in FIGS. 11 and 12, the housing 212 can include a proximal endportion 230 and a distal end portion 232 and can define an inner volume222 therebetween. In some embodiments, the housing 212 can besubstantially similar to a syringe body. The proximal end portion 230 ofthe housing 212 can be substantially open and can be configured toreceive at least a portion of the actuator mechanism 214 such that atleast the portion of the actuator mechanism 214 can be movably disposedwithin the inner volume 222. Furthermore, the inner volume 222 can beconfigured to define the first fluid reservoir 216, as further describedherein. The distal end portion 232 of the housing 212 can include a port220. In some embodiments, the port 220 can be monolithically formed withthe housing 212 (e.g., as shown in FIGS. 11 and 12). In otherembodiments, the port 220 can be coupled to the distal end portion 232in any suitable manner such as, for example, via a friction fit, athreaded coupling, a mechanical fastener, an adhesive, any number ofmating recesses, and/or any combination thereof.

The port 220 can be any suitable shape, size, or configuration. Forexample, in some embodiments, at least a portion of the port 220 canform a lock mechanism configured to be physically and fluidicallycoupled to a peripheral IV line, a Central Venous Catheter (CVC) line, aneedle, a cannula, or other lumen-containing device. For example, insome embodiments, the port 220 can be a LUER-LOK or similar lockingmechanism that can be configured to physically and fluidically couple toa CVC line (not shown). In other embodiments, the port 220 can bemonolithically formed in a unitary, one piece construction with at leasta portion of the lumen-containing device. In this manner, the port 220can be placed in fluid communication with a lumen defined by thelumen-defining device and to receive the bodily-fluid from a patientwhen the lumen-defining device is disposed within the patient.

The actuator mechanism 214 can be disposed within the inner volume 222and can be movable between a first configuration (e.g., a distalposition relative to the housing 212, as shown in FIG. 13) and a secondconfiguration (e.g., a proximal position relative to the housing 212, asshown in FIG. 14). The movement of the actuator mechanism 214 relativeto the housing 212 can move the transfer device 210 between a number ofdifferent configurations and positions, as further described herein. Theactuator mechanism 214 can include a first member 234 and a secondmember 236. The first member 234 of the actuator mechanism 214 caninclude a plunger 244, a locking mechanism 279, and a syringe body 238,where the syringe body 238 and plunger 244 can define an inner volume242. At least a portion of the inner volume 242 can define the secondfluid reservoir 218, as further described herein. The plunger 244 caninclude a plunger seal 240 that can fluidically seal the second fluidreservoir 218. The syringe body 238 can include an open proximal endsuch that the plunger 244 can be movably disposed within the innervolume 242.

The distal end portion of the first member 234 can include an attachmentelement 252, such as a LUER-LOK or similar locking or couplingmechanism, that can be configured to selectively physically andfluidically couple the first member 234 with the second member 236. Theattachment element 252 can be threadedly engaged with the second member236 such that rotation of the first member 234 (e.g., 90 degrees in aclockwise direction) can disengage the first member 234 from the 236.The attachment element 252 can include or can be a port which can, forexample, be similar in construction and operation to port 220 describedherein. It will be appreciated that the attachment element 252 can beselectively attached and decoupled from the second member 236 in anysuitable manner such as, for example, with a threaded engagement, a snapfit, and friction fit, a user-accessible locking mechanism, or the like.

The second member 236 can include a plunger seal 254 that can form afriction fit with the inner surface of the walls defining the innervolume 222 when the actuator mechanism 214 is disposed within thehousing 212. Similarly stated, the plunger seal 254 can define a fluidicseal with the inner surface of the walls defining the inner volume 222such that a portion of the inner volume 222 distal of the plunger seal254 is fluidically isolated from a portion of the inner volume 222proximal of the plunger seal 254. The plunger seal 254 can define achannel 256 that that can extend through a distal end and a proximal endof the plunger seal 254. A portion of an inner set of walls defining thechannel 256 can accept a valve seat 258. In this manner, a portion ofthe channel 256 can receive a valve 260 that can be in contact with thevalve seat 258. The valve 260 can include a threaded proximal end 262that can selectively engage the attachment element 252 of the firstmember 234 as described herein.

The valve 260 can be any suitable valve. For example, in someembodiments, the valve 260 can be a one-way check valve to allow a flowof a fluid from a proximal end of the valve 260 to a distal end of thevalve 260, but substantially not allow a flow of the fluid from thedistal end to the proximal end. The valve 260 can be disposed within thechannel 256 and can be in contact with the valve seat 258 such that thevalve 260 forms a substantially fluid tight seal with the walls definingthe channel 256. In some embodiments, the valve 260 can form a frictionfit with walls defining the channel 256. In other embodiments, the valve260 can form a threaded coupling or the like with at least a portion ofthe walls. The valve 260 can also include a seal member configured toengage the valve seat 258 to form at least a portion of the fluid tightseal.

As described above, the second member 236 can be movably disposed withinthe housing 212. More specifically, the second member 236 can be movablebetween the first configuration (e.g., a distal position) and the secondconfiguration (e.g., a proximal position) to urge the plunger seal 254proximally to create a negative pressure to draw, for example, amedicament, out of a medication vial (not shown) and into the firstfluid reservoir 216. As shown in FIG. 14, to urge the plunger seal 254proximally, a locking mechanism 279 can be engaged with the syringe body238 to at least temporarily couple the plunger 244 and the syringe body238, such that urging the plunger proximally correspondingly moves thesyringe body 238 and the plunger seal 254 proximally. The lockingmechanism 279 can prevent the plunger 244 from moving proximally andlaterally relative to the syringe body 238 such that the second fluidreservoir 218 remains substantially unaffected and static. The plunger244 can be urged proximally to a pre-set, predetermined, or userdetermined volume, where the second position can include retaining adesirable amount of a fluid (e.g., a medicament or biologic) in thefirst fluid reservoir 216. In the second position, as shown in FIG. 14,the transfer device 210 can be in a configuration ready to deliver thecontents of the first fluid reservoir 216 and subsequently the contentsof the second fluid reservoir 218 to the patient.

It will be appreciated that the any suitable locking mechanism 279 iscontemplated. As illustrated, it may be desirable to prevent relativemovement between the plunger 244 and the syringe body 238 in both theproximal and distal direction until the fluid in the first fluidreservoir 216 has drawn (e.g., from a medicament vial) and then fullydispensed (e.g., into a patient's line). The locking mechanism 279 caninclude a radial projection 280 that can be pivotable radially outwardabout a pin 285, where the pin 285 can be at least partially retained byan aperture 283 defined by the plunger shaft 248. In a first lockedposition, the radial projection can be pivoted outward such that it issubstantially perpendicular to the axis of motion of the plunger 244.The radial projection 280 can include a pin 285 that can engage a catch287 or aperture defined by the syringe body 238 when the lockingmechanism 279 is in the locked position. As shown in FIG. 14, in theclosed position, the pin 285 engaged with the catch 287 can result inproximal movement of the syringe body 238 when the plunger 244 iscorrespondingly moved in the proximal direction. Temporarily couplingthe plunger 244 and the syringe body in the proximal direction can allowfor translation of the plunger 244 to draw the plunger seal 254proximally to draw medicament, or the like, into the first fluidreservoir 216. It will be appreciated that the features of the lockingmechanism 279, including the pin 285 and catch 287, are described by wayof example only, where any suitable stop, clasp, engagement, coupling,or the like is contemplated.

The transfer device 210 can be transitioned between the secondconfiguration (e.g., the proximal position) and a third configuration(e.g., the distal position) to urge the plunger seal 254 distally tocreate a create positive pressure to urge, for example, a medicament outof the first fluid reservoir 216. As shown in FIG. 15, the radialprojection 280 of the locking mechanism 279 can define a cutout or stop284 that can engage the proximal surface 281 of the syringe body 238. Asshown in FIG. 15, in the closed position, the locking mechanism 279 willresult in distal movement of the plunger 244 correspondingly moving thesyringe body 238 in the distal direction. In this manner the lockingmechanism 279 can help insure that the fluid in the first fluidreservoir 216 is expelled before the fluid in the second fluid reservoir218 is expelled.

The transfer device 210 can be transitioned between the thirdconfiguration and a fourth configuration to urge the plunger seal 240distally to create a create positive pressure to urge, for example, asaline flush out of the second fluid reservoir 218. As shown in FIG. 16,after the plunger 244 has been depressed to expel the fluid from thefirst fluid reservoir 216, the radial projection 280 can be pivoted, forexample, about 90 degrees, such that the radial projection 280 issubstantially parallel to the axis of motion of the plunger 244. In this“open” position, as illustrated in FIG. 16, the radial projection 280does not interfere with the proximal surface 281 of the syringe body238, where the radial projection 280 can now pass within the syringebody 238. In use, after the fluid has been dispensed from the firstfluid reservoir 216, the locking mechanism 279 can be “opened” ortransitioned to the second position such that the plunger 244 can bedepressed to expel fluid from the second fluid reservoir 218.

FIGS. 17-23 illustrate a syringe-based transfer device 310, where thetransfer device 310 can include a pre-filled saline or flush fluid,according to an embodiment. It may be beneficial to provide a syringehaving a pre-filled or predetermined amount of a fluid, such as a 10 mlor 20 ml saline flush, to which a standard syringe can be attached forthe delivery of a medicine. It may also be beneficial to provide asystem, such as with transfer device 310, where a first flush can beprovided, followed by delivery of a medicine, which can then be followedby a second flush, all of which can be performed with a single orintegrated unit or system. Providing such a three step delivery systemin a single unit can save the clinician from performing multipleadditional steps (e.g., screwing and unscrewing various components) toaccomplish the same goal. Minimizing the number of such steps may bebeneficial when giving medications through a central venous catheter,where instead of three cap entries, there may only be one. Such systemsmay save time and increase compliance of flushing a line before andafter medications. In regards to neonates and pediatrics, such systemscan increase the efficacy of life saving medications by advancing themedication to the central compartment where the medication is mosteffective. Having a flush/push/flush process can help assure that theline is patent before administering medications without having to firstattach a separate flush device. Such systems may be useful with a widerange of medications, such as valium, where providing an initial flushmay prevent the medication from crystalizing within a catheter due to ahigh tendency for incompatibility with other medications and Intravenousfluids. Many times patients will have to undergo unnecessary surgeriesto repair or replace lines that have been crystalized and, becauseValium is generally given on every oncology unit for nausea, it may bebeneficial to mitigate this risk.

The syringe-based transfer device 310 (also referred to herein as “fluidtransfer device,” “transfer device”, “integrated flush device,” or “drugdelivery device”) includes a housing 312 and an actuator mechanism 314.The transfer device 310 can, in a pre-use configuration, include a firstfluid reservoir 316 (also referred to herein as “first reservoir” or“flush reservoir”) and a plunger 344. The transfer device 310 can be anysuitable shape, size, or configuration. For example, while shown inFIGS. 17 and 18 as being substantially cylindrical, the transfer device310 can be square, rectangular, polygonal, and/or any othernon-cylindrical shape.

As shown in FIGS. 17 and 18, the housing 312 can include a proximal endportion 330 and a distal end portion 332 and can define an inner volume322 therebetween. In some embodiments, the housing 312 can besubstantially similar to a syringe body. The proximal end portion 330 ofthe housing 312 can be substantially open and can be configured toreceive at least a portion of the actuator mechanism 314, such as theplunger 344 in the pre-use configuration, such that at least the portionof the actuator mechanism 314 can be movably disposed within the innervolume 322. Furthermore, the inner volume 322 can be configured todefine the first fluid reservoir 316, as further described herein.

The housing 312 can include a partitioning assembly 331, abutmentassembly, or the like, positioned at about the distal end portion 332 ofthe housing 312. The partitioning assembly 331 can include a concavedisk 333, or a substantially disk-shaped feature or abutment, that canbe shaped to correspond substantially to a distal end 335 of a plungerseal 354 of the actuator mechanism 314, as will be described in moredetail herein. The concave disk 333 can function as a bulkhead and canbe attached to, or can be monolithically formed as a unitary, one piececonstruction with the housing 312. The concave disk 333 can bemonolithically formed, such as in a unitary, one piece construction,with a cylinder 337 defining a lumen 339. In one embodiment, the lumen339 can be 14 gauge and can be fluidically coupled with the first fluidreservoir 316. The concave disk 333, the cylinder 337, and the housing312 can cooperate to define a cavity 341 that can be sealed and can bedead space. It will be appreciated that the concave disk 333 or abutmentcan have any suitable shape, position, or configuration.

The distal end portion 332 of the housing 312 can include a port 320. Insome embodiments, the port 320 can be monolithically formed with thehousing 312 (e.g., as shown in FIGS. 17 and 18) and/or the cylinder 337.The port 320 can be fluidically coupled with the lumen 339 defined bythe cylinder 337. In other embodiments, the port 320 can be coupled tothe distal end portion 332 in any suitable manner such as, for example,via a friction fit, a threaded coupling, a mechanical fastener, anadhesive, any number of mating recesses, and/or any combination thereof.The port 320 can be any suitable shape, size, or configuration. Forexample, in some embodiments, at least a portion of the port 320 canform a lock mechanism configured to be physically and fluidicallycoupled to a peripheral IV line, a Central Venous Catheter (CVC) line, aneedle, a cannula, or other lumen-containing device. For example, insome embodiments, the port 320 can be a LUER-LOK, SLIP-TIP, or similarlocking mechanism, attachment mechanism, or the like, that can beconfigured to physically and fluidically couple to a CVC line (notshown). In other embodiments, the port 320 can be monolithically formedin a unitary, one piece construction with at least a portion of thelumen-containing device. In this manner, the port 320 can be placed influid communication with a lumen defined by the lumen-defining deviceand to receive the bodily-fluid from a patient when the lumen-definingdevice is disposed within the patient.

The actuator mechanism 314 can be disposed within the inner volume 322and can be movable between a first configuration (e.g., a proximalposition relative to the housing 312, shown in FIG. 19) and a secondconfiguration (e.g., a more distal position relative to the housing 312,shown in FIG. 20). The movement of the actuator mechanism 314 relativeto the housing 312 can move the transfer device 310 between a number ofdifferent configurations and positions, as further described herein. Theactuator mechanism 314, in the first and second configuration, caninclude the plunger 344, which can be detachable. The distal end portion332 of the plunger 344 can include an attachment element 352, such as aLUER-LOK or similar locking or coupling mechanism, that can beconfigured to selectively couple with a plunger assembly 336. Theattachment element 352 can be threadedly engaged with the plungerassembly 336 such that rotation of the plunger 344 (e.g., 90 degrees ina clockwise direction) will disengage the plunger 344 from the plungerassembly 336. It will be appreciated that the plunger 344 can beselectively attached and decoupled from the plunger assembly 336 in anysuitable manner such as, for example, with a threaded engagement, a snapfit, and friction fit, a user-accessible locking mechanism, or the like.

The plunger assembly 336 (FIG. 17) can include a plunger seal 354 thatcan form a friction fit with the inner surface of the walls defining theinner volume 322 when the actuator mechanism 314 is disposed within thehousing 312. Similarly stated, the plunger seal 354 can define a fluidicseal with the inner surface of the walls defining the inner volume 322such that a portion of the inner volume 322 distal of the plunger seal354 is fluidically isolated from a portion of the inner volume 322proximal of the plunger seal 354. The plunger seal 354 can define achannel 356 that that can extend through a distal end and a proximal endof the plunger seal 354. A portion of an inner set of walls defining thechannel 356 can accept a valve seat 358, where the valve seat can have acannula 343 extending from the valve seat 358, through the channel 356,and distally from the distal end of the plunger seal 354. The plungerseal 354 can receive a valve 360 that can be in contact with the valveseat 358. The valve 360 can include a proximal threaded end 362 that canselectively engage the attachment element 352 of the plunger 344 duringthe first and second positions.

The valve 360 can be any suitable valve. For example, in someembodiments, the valve 360 can be a one-way check valve to allow a flowof a fluid from a proximal end of the valve 360 to a distal end of thevalve 360, but substantially not allow a flow of the fluid from thedistal end to the proximal end. The valve 360 can be disposed within thechannel 356 and can be in contact with the valve seat 358 such that thevalve 360 forms a substantially fluid tight seal with the walls definingthe channel 356. In some embodiments, the valve 360 can form a frictionfit with walls defining the channel 356. In other embodiments, the valve360 can form a threaded coupling or the like with at least a portion ofthe walls. The valve 360 can also include a seal member configured toengage the valve seat 358 to form at least a portion of the fluid tightseal. The cannula 343 can have any suitable length such as, for example,from about 10 mm to about 20 mm, from about 5 mm to about 25 mm, fromabout 5 mm to about 10 mm, or any other suitable combination or fractionthereof.

The plunger assembly 336 can be movably disposed within the housing 312.More specifically, the plunger assembly 336 can be movable between afirst position (e.g., a proximal position) and a second position (e.g.,a more distal position) to urge the plunger seal 354 distally to createa positive pressure to urge, for example, a first amount of flush fluidout of the first fluid reservoir 316. Displacing the plunger 344distally can urge the plunger seal 354 distally such that a first amountof fluid is pushed out of the first fluid reservoir 316, through thelumen defined by the cylinder 337, and out the port 320. The plunger 344can be urged proximally to a pre-set, predetermined, or user determinedvolume, where the second position can include delivering a first amountof fluid (e.g., 5 ml of saline) the first fluid reservoir 316. In thesecond position, the transfer device 310 can have dispelled a portion ofthe contents of the first fluid reservoir 316 such as, for example,about 50 percent, from about 25 percent to about 75 percent, from about10 percent to about 50 percent, or any fraction thereof. Transitioningthe transfer device from the first position to the second position candeliver a first flush amount of a first type of fluid, such as a 5 mlflush of saline, which may be desirable to administer to a patientbefore delivering a bolus amount of a second type of fluid, such as amedication, for example.

In certain embodiments, it may be beneficial to prime or dispense asmall amount of flush fluid from the first fluid reservoir 316 beforedelivering the first amount of flush fluid to the patient. In suchembodiments the first fluid reservoir 316 can be pre-filled with anamount of fluid, such as 10.5 ml of saline, where 0.5 ml of the fluid isintended to be used to prime the transfer device 310. To accuratelydeliver only the appropriate amount of priming fluid, where deliveringtoo much fluid may accidentally expel fluid associated with the flush,as will be described in more detail herein, the housing can include afirst annular band 345 that can create an interference fit with theplunger seal 354. The first annular band 345 can project inwardly intothe inner volume 322 defined by the housing, where the first annularband 345 can be sized to temporarily restrict distal movement of theplunger seal 354, but where the interference fit between the plungerseal 354 and the first annular band 345 can easily be defeated. In apre-used configuration, where priming is desirable, the plunger seal 354can be positioned just proximal to the first annular band 345 such thatthe first fluid reservoir 316 contains a desirable flush amount of fluidand a desirable priming amount of fluid. The plunger seal 354 can beadvanced by depressing the plunger 344 until the plunger seal engagesthe first annular band 345 in an interference fit. This can be sizedsuch that when the user encounters the interference fit they can easilyrecognize that the proper amount of priming fluid has been dispensed.

In accordance with transitioning the transfer device 310 from the firstposition to the second position, to deliver the first amount of flushfluid the plunger 344 can be advanced farther distally such that theinterference fit is overcome. The plunger 344 can be depressed until asecond interference between the plunger seal 354 and a second annularband 347 indicates that the appropriate volume of a first fluid (e.g., 5ml) has been delivered. Transitioning the transfer device 310 from thefirst position to the second position can also distally translate thecannula 343 such that the cannula 343 advances within the lumen 339defined by the cylinder 337. In the second configuration, the cannula343 can be positioned sufficiently proximate the port 320 that fluiddelivered through the cannula 343 will pass out of the port 320 and intoa patient and/or lumen-defining device. The cannula 343 can advance, forexample, from about 5 mm to about 10 mm, from about 3 mm to about 12 mm,from about 1 mm to about 15 mm, or any fractional distance thereofduring the transition from the first configuration to the secondconfiguration. Providing a first fluid flush in accordance with thetransition from the first configuration to the second configuration candeliver a sufficient amount of flush fluid (e.g., 5 ml of saline) toclear a lumen-defining device of a patient (e.g., a CVC line).

With reference to FIG. 21, the transfer device 310 can be transitionedfrom the second configuration to a third configuration by selectivelyremoving the plunger 344. In one embodiment, the plunger 344 can beremoved by unthreading the attachment element 352 from the proximalthreaded end 362 of the valve 360. The plunger 344 can be discardedafter being removed from the transfer device 310. In one embodiment,providing the transfer device 310 with the plunger 344 during shipmentand prior to use can also function to keep the valve 360 substantiallysterile and/or free of contaminants. The transfer device 310 can furtherbe transitioned from the second configuration to the third configurationby selectively attaching a syringe 390. The syringe 390 can have asyringe body 338 that can define a second fluid reservoir 318. Syringebody 338 can include a plunger 392 that can translate distally withinthe syringe body 338 to expel the fluid from the second fluid reservoir318. Any suitable fluid, such as a pre-filled amount of a medicament orbiologic, can be used to fill the second fluid reservoir 318. Thesyringe body 338 can include a port 349, which can be similar inconstruction and operation to port 320, at a distal end thereof. Theport 349 can include a LUER-LOK, or any other suitable attachmentmechanism. The syringe body 338 can be fluidly coupled to the plungerassembly 336 by threadedly engaging the port 349 with the proximalthreaded end 362 of the valve 360.

As shown in FIG. 22, the transfer device 310 can be transitioned fromthe third configuration to a fourth configuration by depressing theplunger 392 such that the fluid retained within the second fluidreservoir 318 is expelled through the port 349. The port 349 and theplunger assembly 336 can be fluidically coupled such that fluid passesout of the second fluid reservoir 318, through the valve 360, throughthe cannula 343, and out through the port 320 into the patient. Thesyringe 390 can be any suitable syringe, such as a pre-filled syringe ora syringe drawn by a clinician to contain a desirable amount of a fluid.The second fluid reservoir 318 can contain any suitable medication orbiologic such as, for example, atropine, etomidate, rocuronium,succinylcholine, epinephrine, NARCAN, amiodarone, or the like. Thesecond fluid reservoir 318 can contain any suitable volume of fluid suchas, for example, from about 0.1 ml to about 3.0 ml. In still otherembodiments, the second fluid reservoir 318 can contain from about 3.0ml, 4.0 ml, 5.0 ml, 6.0 ml, 7.0 ml, 8.0 ml, 9.0 ml, 10.0 ml, 15.0 ml,20.0 ml, 25.0 ml, 50 ml, or any volume or fraction of volumetherebetween. Providing the delivery of a medication or biologic after afirst fluid flush may effectively clear the patient's line and/orminimize the chance that the medication will interact with undesirablefluids or materials present in the patient's line.

The transfer device 310 can be transitioned between the fourth positionto a fifth position to urge the plunger seal 354 distally to create acreate positive pressure to urge, for example, a second amount of fluidout of the first fluid reservoir 316. In certain embodiments, thesyringe 390 can function as the plunger in place of the removed plunger344, where distally advancing the syringe 390 can concurrently translatethe plunger assembly 336 distally. As shown in FIG. 23, after theplunger 392 has been depressed to expel the fluid from the second fluidreservoir 318, continually depressing the plunger 392 and/or syringe 390can actuate the plunger seal 354 distally until it is seated against aproximal surface of the concave disk 333. The distal end 335 of theplunger seal 354 can substantially match the shape of the concave disk333 such that substantially all of the fluid is expelled from the firstfluid reservoir 316. Delivering a second amount of fluid in a secondflush can urge the medication or other fluid administered from the firstfluid reservoir 316 farther along the attached lumen-defining device(e.g., a CVC line).

In one example, the first fluid reservoir 316 of the transfer device 310can be filled with 10.5 ml of saline. The plunger 344 can be distallyactuated to prime the transfer device by expelling 0.5 ml of saline fromthe first fluid reservoir. The port 320 of the transfer device 310 canthen be engaged with a CVC line of a patient. The plunger 344 can thenbe depressed to deliver a first 5 ml amount of saline to flush the CVCline. The plunger 344 can be threadedly disengaged from the plungerassembly 336 and discarded. A syringe 390 containing 1 ml of epinephrinecan be threadedly engaged with the plunger assembly 336 and dispensedinto the CVC line of the patient. The syringe 390 can then be advancedto deliver the second 5 ml amount of saline to flush the CVC line and tofacilitate the epinephrine traveling to the heart or other desiredtarget. It will be appreciated that any suitable volume of first flush,medicament, and second flush is contemplated. The first flush and thesecond flush amounts can be of the same amount, can be differentamounts, can be of the same type, or can be of different types. Forexample, the second flush amount may include heparin in someapplications. It will be appreciated that different medications may havedifferent associated volumes and associated flush volumes. It will beappreciated that different combinations of medication and/or flushstages are contemplated including, for example, a medication followed bya first flush and then a second flush, a first flush and a second flushfollowed by a medication, a first flush followed by a first medication,a second flush, a second medication, and then a third flush, or thelike. It will be appreciated that multiple stages including two stages,three stages, four stages, five stages, and six stages can be combinedinto a single syringe-based device. It will be appreciated that multiplemulti-stage syringe systems can be used in combination for variousprocedures.

FIGS. 24-31 illustrate a syringe-based transfer device 410, where thetransfer device 410 can include a pre-filled saline or flush fluid,according to an embodiment. It may be beneficial to provide a syringehaving a pre-filled or predetermined amount of a fluid, such as a 10 mlor 20 ml saline flush, to which a standard syringe can be attached forthe delivery of a medicine. It may also be beneficial to provide asystem, such as with transfer device 410, where a first flush can beprovided, followed by delivery of a medicine, which can then be followedby a second flush. The syringe-based transfer device 410 (also referredto herein as “fluid transfer device,” “transfer device”, “integratedflush device”, or “drug delivery device”) includes a housing 412 and anactuator mechanism 414. The transfer device 410 can, in a pre-useconfiguration, include a first fluid reservoir 416 (also referred toherein as “first reservoir” or “flush reservoir”), a plunger assembly436, and a seal 451 or cap. The transfer device 410 can be any suitableshape, size, or configuration. For example, while shown in FIGS. 24 and25 as being substantially cylindrical, the transfer device 410 can besquare, rectangular, polygonal, and/or any other non-cylindrical shape.

As shown in FIGS. 25 and 26, the housing 412 can include a proximal endportion 430 and a distal end portion 432 and can define an inner volume422 therebetween. In some embodiments, the housing 412 can besubstantially similar to a syringe body. The proximal end portion 430 ofthe housing 412 can be open and can receive the seal 451. The seal 451can be any suitable cap, plug, tear away foil, or the like that canmaintain the inner volume 422 of the housing 412 in a sterile and/oruncontaminated state prior to use. The seal 451 can include identifyinginformation, tamper resistant features, features to prevent thereattachment of the seal 451, or the like. As shown in FIG. 27, the seal451 can be removed in any suitable manner such as by tearing the seal,unscrewing a cap, overcoming an interference fit, or the like.

The housing 412 can include a partitioning assembly 431 positioned atabout the distal end portion 432 of the housing 412. The partitioningassembly 431 can include a concave disk 433 that can be shaped tocorrespond substantially to a distal end 435 of a plunger seal 454 ofthe actuator mechanism 414, as will be described in more detail herein.The concave disk 433 can function as a bulkhead or abutment and can beattached to, or can be monolithically formed as a unitary, one piececonstruction with the housing 412. The concave disk 433 can bemonolithically formed, such as in a unitary, one piece construction,with a cylinder 437 defining a lumen 439. In one embodiment, the lumen439 can be 14 gauge and can be fluidically coupled with the first fluidreservoir 416. The concave disk 433, the cylinder 437, and the housing412 can cooperate to define a cavity 441 that can be sealed and can bedead space.

The distal end portion 432 of the housing 412 can include a port 420. Insome embodiments, the port 420 can be monolithically formed with thehousing 412 (e.g., as shown in FIGS. 24 and 25) and/or the cylinder 437.The port 420 can be fluidically coupled with the lumen 439 defined bythe cylinder 437. In other embodiments, the port 420 can be coupled tothe distal end portion 432 in any suitable manner such as, for example,via a friction fit, a threaded coupling, a mechanical fastener, anadhesive, any number of mating recesses, and/or any combination thereof.The port 420 can be any suitable shape, size, or configuration. Forexample, in some embodiments, at least a portion of the port 420 canform a lock mechanism configured to be physically and fluidicallycoupled to a peripheral IV line, a Central Venous Catheter (CVC) line, aneedle, a cannula, or other lumen-containing device. For example, insome embodiments, the port 420 can be a LUER-LOK, SLIP-TIP, or similarlocking mechanism, attachment mechanism, or the like, that can beconfigured to physically and fluidically couple to a CVC line (notshown). In other embodiments, the port 420 can be monolithically formedin a unitary, one piece construction with at least a portion of thelumen-containing device. In this manner, the port 420 can be placed influid communication with a lumen defined by the lumen-defining deviceand to receive the bodily-fluid from a patient when the lumen-definingdevice is disposed within the patient.

The transfer device 410 can be transitioned from a first configuration(e.g., FIG. 26) to a second configuration (e.g., FIG. 27) by removingthe seal 451. As shown in FIG. 28, the transfer device 410 can betransitioned from the second configuration to a third configuration byinserting at least a portion of the actuator mechanism 414 into theinner volume 422 of the housing 412. A port 449 at a distal end of theactuator mechanism 414 can be selectively engaged with the plungerassembly 436. The actuator mechanism 414 can be coupled with the plungerassembly 436 such that the actuator mechanism 414 is moveable relativeto the housing 412. The movement of the actuator mechanism 414 relativeto the housing 412 can move the transfer device 410 between a number ofdifferent configurations and positions, as further described herein. Thedistal end of the actuator mechanism 414 can include an attachmentelement 452, such as a LUER-LOK or similar locking or couplingmechanism, that can be configured to selectively physically and/orfluidically couple with the plunger assembly 436. The actuator mechanism414 can be threadedly engaged with the plunger assembly 436 such thatrotation of the actuator mechanism 414 (e.g., 90 degrees in acounterclockwise direction) can engage the actuator mechanism 414 withthe plunger assembly 436. It will be appreciated that the actuatormechanism 414 can be selectively attached and decoupled from the plungerassembly 436 in any suitable manner such as, for example, with athreaded engagement, a snap fit, and friction fit, a user-accessiblelocking mechanism, or the like.

The actuator mechanism 414, in one embodiment, can include a syringe 490that can be pre-filled with any suitable medicament, biologic, or thelike. The syringe 490 can have a syringe body 438 that can define asecond fluid reservoir 418. The syringe 490 can include a plunger 492that can translate distally within the syringe body 438 to expel thefluid from the second fluid reservoir 418. Any suitable fluid, such as apre-filled amount of a medicament or biologic, can be used to fill thesecond fluid reservoir 418.

The plunger assembly 436 can include a plunger seal 454 that can form afriction fit with the inner surface of the walls defining the innervolume 422. Similarly stated, the plunger seal 454 can define a fluidicseal with the inner surface of the walls defining the inner volume 422such that a portion of the inner volume 422 distal of the plunger seal454 is fluidically isolated from a portion of the inner volume 422proximal of the plunger seal 454. The plunger seal 454 can define achannel 456 that that can extend through a distal end and a proximal endof the plunger seal 454. A portion of an inner set of walls defining thechannel 456 can accept a valve seat 458, where the valve seat 458 canhave a cannula 443 extending from the valve seat 458, through thechannel 456, and distally from the distal end of the plunger seal 454.The plunger seal 454 can receive a valve 460 that can be in contact withthe valve seat 458. The valve 460 can include a threaded proximal end462 that can selectively engage the attachment element 452 of theactuator mechanism 414. In certain embodiments, as illustrated in FIG.25, the plunger assembly 436 can be an integral component where one or aplurality of the plunger seal 454, the cannula 443, the valve seat 458,and the valve 460 can be monolithically formed such that they are of aunitary, one piece construction.

The valve 460 can be any suitable valve. For example, in someembodiments, the valve 460 can be a one-way check valve to allow a flowof a fluid from a proximal end of the valve 460 to a distal end of thevalve 460, but substantially not allow a flow of the fluid from thedistal end to the proximal end. The valve 460 can be disposed within thechannel 456 and can be in contact with the valve seat 458 such that thevalve 460 forms a substantially fluid tight seal with the walls definingthe channel 456. In some embodiments, the valve 460 can form a frictionfit with walls defining the channel 456. In other embodiments, the valve460 can form a threaded coupling or the like with at least a portion ofthe walls. The valve 460 can also include a seal member configured toengage the valve seat 458 to form at least a portion of the fluid tightseal. The cannula 443 can have any suitable length such as, for example,from about 10 mm to about 20 mm, from about 5 mm to about 25 mm, fromabout 5 mm to about 10 mm, or any other suitable combination or fractionthereof.

The plunger assembly 436 can be movably disposed within the housing 412to transition the fluid transfer device 410 from the secondconfiguration to the third configuration. As shown in FIG. 29, theplunger assembly 436 can be movable to urge the plunger seal 454distally to create a positive pressure to urge, for example, a firstamount of flush fluid out of the first fluid reservoir 416. Displacingthe actuator mechanism 414 distally can urge the plunger seal 454distally such that a first amount of fluid is pushed out of the firstfluid reservoir 416, through the lumen 439 defined by the cylinder 437,and out the port 420. The actuator mechanism 414 can be urged distallyto a pre-set, predetermined, or user determined volume, where the distalactuation can include delivering a first amount of fluid (e.g., 5 ml ofsaline) from the first fluid reservoir 416. In the third configuration,the transfer device 410 can have expelled a portion of the contents ofthe first fluid reservoir 416 such as, for example, about 50 percent,from about 25 percent to about 75 percent, from about 10 percent toabout 50 percent, or any fraction thereof. Transitioning the transferdevice 410 from the second configuration to the third configuration candeliver a first flush amount of a first type of fluid, such as a 5 mlflush of saline, which may be desirable to administer to a patientbefore delivering a bolus amount of a second type of fluid, such as amedication, for example.

In certain embodiments, it may be beneficial to prime or dispense asmall amount of flush fluid from the first fluid reservoir 416 beforedelivering the first amount of flush fluid to the patient. In suchembodiments the first fluid reservoir 416 can be pre-filled with anamount of fluid, such as 10.5 ml of saline, where 0.5 ml of the fluid isintended to be used to prime the transfer device 410. To accuratelydeliver only the appropriate amount of priming fluid, where deliveringtoo much fluid may accidentally expel fluid associated with the flush,as will be described in more detail herein, the housing 412 can includea first annular band 445 that can form an interference fit with theplunger seal 454. The first annular band 445 can project inwardly intothe inner volume 422 defined by the housing 412, where the first annularband 445 can be sized to temporarily restrict distal movement of theplunger seal 454, but where the interference fit between the plungerseal 454 and the first annular band 445 can easily be defeated, butstill provide tactile feedback to the user. In a pre-use configuration,where priming is desirable, the plunger seal 454 can be positioned justproximal to the first annular band 445 such that the first fluidreservoir 416 contains a desirable flush amount of fluid and a desirablepriming amount of fluid. The plunger seal 454 can be advanced bydepressing the actuator mechanism 414 until the plunger seal 454 engagesthe first annular band 445 in an interference fit. This can be sizedsuch that when the user encounters the interference fit they can easilyrecognize that the proper amount of priming fluid has been dispensed.

In accordance with transitioning the transfer device 410 from the secondconfiguration to the third configuration, the actuator mechanism 414 canbe advanced distally to overcome the interference fit between the firstannular band 445 and the plunger seal 454. The actuator mechanism 414can be depressed until a second interference between the plunger seal454 and a second annular band 447 indicates that the appropriate volumeof a first fluid (e.g., 5 ml of saline) has been delivered.Transitioning the transfer device 410 from the second configuration tothe third configuration can also distally translate the cannula 443 suchthat the cannula 443 advances within the lumen 439 defined by thecylinder 437. In the third configuration, as shown in FIG. 29, thecannula 443 can be positioned sufficiently proximate the port 420 thatfluid delivered through the cannula 443 will pass out of the port 420and into a patient and/or lumen-defining device. The cannula 443 canadvance, for example, from about 5 mm to about 10 mm, from about 3 mm toabout 12 mm, from about 1 mm to about 15 mm, or any fractional distancethereof during the transition from the second configuration to the thirdconfiguration. Providing a first fluid flush in accordance with thetransition from the second configuration to the third configuration candeliver a sufficient amount of flush fluid (e.g., 5 ml of saline) toclear a lumen-defining device of a patient (e.g., a CVC line).

As shown in FIG. 30, the transfer device 410 can be transitioned fromthe third configuration to a fourth configuration by depressing theplunger 492 such that the fluid retained within the second fluidreservoir 418 is expelled through the port 449. The port 449 and theplunger assembly 436 can be fluidically coupled such that fluid passesout of the second fluid reservoir 418, through the valve 460, throughthe cannula 443, through the port 420, and into the patient and/orlumen-defining device. The syringe 490 can be any suitable syringe, suchas a pre-filled syringe or a syringe drawn by a clinician to contain adesirable amount of a fluid. The second fluid reservoir 418 can containany suitable medication or biologic such as, for example, atropine,etomidate, rocuronium, succinylcholine, epinephrine, NARCAN, amiodarone,or the like. The second fluid reservoir 418 can contain any suitablevolume of fluid such as, for example, from about 0.1 ml to about 3.0 ml.In still other embodiments, the second fluid reservoir 418 can containfrom about 3.0 ml, 4.0 ml, 5.0 ml, 6.0 ml, 7.0 ml, 8.0 ml, 9.0 ml, 10.0ml, 15.0 ml, 20.0 ml, 25.0 ml, 50 ml, or any volume or fraction ofvolume therebetween. Providing the delivery of a medication or biologicafter a first fluid flush may effectively clear the patient's lineand/or minimize the chance that the medication will interact withundesirable fluids or materials present in the patient's line.

As shown in FIG. 31, the transfer device 410 can be transitioned fromthe fourth configuration to a fifth configuration to urge the plungerseal 454 distally to create positive pressure to urge, for example, asecond amount of fluid out of the first fluid reservoir 416. Distallyadvancing the syringe 490 can concurrently translate the plungerassembly 436 distally. As shown in FIG. 31, after the plunger 492 hasbeen depressed to expel the fluid from the second fluid reservoir 418,continually depressing the plunger 492 and/or syringe 490 can actuatethe plunger seal 454 distally until it is seated against a proximalsurface of the concave disk 433. The distal end 435 of the plunger seal454 can substantially match the shape of the concave disk 433 such thatsubstantially all of the fluid is expelled from the first fluidreservoir 416. Delivering a second amount of fluid in a second flush canurge the medication or other fluid administered from the first fluidreservoir 416 farther along the attached lumen-defining device (e.g., aCVC line).

FIG. 32 illustrates a syringe-based transfer device 510, where thetransfer device 510 can include an alternate locking mechanism 579according to an embodiment. The operation of the transfer device 510 canbe the same or substantially similar to the operation of transfer device410, as described herein. It may be determined that a robust lockingmechanism 579 may be beneficial to provide a clinician with clearguidance on when the transfer device 510 is primed, when the firstportion of flush fluid has been delivered, and an additional assurancethat the second amount of fluid flush will not be delivered until afterthe medication has been delivered. As described herein, it may bebeneficial to provide a system, such transfer device 510, where a firstflush can be provided, followed by delivery of a medicine, which canthen be followed by a second flush. The syringe-based transfer device510 (also referred to herein as “fluid transfer device,” “transferdevice”, “integrated flush device”, or “drug delivery device”) includesa housing 512 and an actuator mechanism 514.

The actuator mechanism 514, in one embodiment, can include a syringe 590that can be pre-filled with any suitable medicament, biologic, or thelike. The syringe 590 can have a syringe body 538 that can define asecond fluid reservoir 518. The syringe 590 can include a plunger 592that can translate distally within the syringe body 538 to expel thefluid from the second fluid reservoir 518. Any suitable fluid, such as apre-filled amount of a medicament or biologic, can be used to fill thesecond fluid reservoir 518.

A plunger assembly 536 can include a plunger seal 554 that can form afriction fit with the inner surface of the walls defining an innervolume 522 of a housing 512. Similarly stated, the plunger seal 554 candefine a fluidic seal with the inner surface of the walls defining theinner volume 522 such that a portion of the inner volume 522 distal ofthe plunger seal 554 is fluidically isolated from a portion of the innervolume 522 proximal of the plunger seal 554. The plunger seal 554 candefine a channel (not shown) that that can extend through a distal endand a proximal end of the plunger seal 554. A portion of an inner set ofwalls defining the channel can accept a valve 560, where the valve 560can have a cannula 543 extending from the valve 560, through thechannel, and distally from the distal end of the plunger seal 554. Thevalve 560 can be any suitable valve. For example, in some embodiments,the valve 560 can be a one-way check valve to allow a flow of a fluidfrom a proximal end of the valve 560 to a distal end of the valve 560,but substantially not allow a flow of the fluid from the distal end tothe proximal end. The plunger assembly 536 can include at least onesemi-circular projection 581 that is coupled with or monolithicallyformed with the plunger seal 554 such that the at least onesemi-circular projection 581 extends in a generally proximal directionrelative to the plunger seal 554. The at least one semi-circularprojection 581 can be shaped to correspond to the walls of the housing512. The at least one semi-circular projection 581 can define anaperture 584, where a flexible tab or living hinge 585 can be at leastpartially positioned within the aperture 584. The living hinge 585 canbe biased radially outward and can be sufficiently flexible that a usercan depress the living hinge 585 such that it will move relative to theat least one semi-circular projection 581.

The plunger assembly 536 can be movably disposed within the housing 512.More specifically, the plunger assembly 536 can be movable to urge theplunger seal 554 distally to create a positive pressure to urge, forexample, a first amount of flush fluid out of the first fluid reservoir516. The housing 512 can define a first aperture 587 and a secondaperture 589, where the first aperture 587 and the second aperture 589can be spaced apart on the same linear axis. The first aperture 587 andthe second aperture 589 can be through holes that pass through housing512. Displacing the actuator mechanism 514 distally can urge the plungerseal 554 distally such that a first amount of fluid is pushed out of thefirst fluid reservoir 516. When the transfer device 510 is properlyprimed the living hinge 585 can engage the first aperture 587 to preventrelative movement between the actuator mechanism 514 and the housing512. Next, the actuator mechanism 514 can be freed to move distally bydepressing the living hinge 585 such that the living hinge 585disengages the first aperture 587. Simultaneous application of pressurein a distal direction to the actuator mechanism 514 can urge the plungerseal 554 distally to a pre-set, predetermined, or user determinedvolume, where the distal actuation can include delivering a first amountof fluid (e.g., 5 ml of saline) from the first fluid reservoir 516. Whenthe pre-determined volume has been delivered the living hinge 585 canengage the second aperture 589 such that relative movement between theactuator mechanism 514 and the housing 512 is again prevented. In such aconfiguration the transfer device 510 can have expelled a portion of thecontents of the first fluid reservoir 516 such as, for example, about 50percent, from about 25 percent to about 75 percent, from about 10percent to about 50 percent, or any fraction thereof. Providing a firstfluid flush can deliver a sufficient amount of flush fluid (e.g., 5 mlof saline) to clear a lumen-defining device of a patient (e.g., a CVCline).

The transfer device 510 can be used to administer a medication orbiologic, for example, by depressing the plunger 592 of the syringe 590such that the fluid retained within the second fluid reservoir 518 isexpelled. The syringe 590 can be any suitable syringe, such as apre-filled syringe or a syringe drawn by a clinician to contain adesirable amount of a fluid. The second fluid reservoir 518 can containany suitable medication or biologic such as, for example, atropine,etomidate, rocuronium, succinylcholine, epinephrine, NARCAN, amiodarone,or the like. Providing the delivery of a medication or biologic after afirst fluid flush may effectively clear the patient's line and/orminimize the chance that the medication will interact with undesirablefluids or materials present in the patient's line. During delivery ofthe medication, for example, the living hinge 585 can engage the secondaperture 589 to resist distal movement of the plunger seal 554 while thesyringe 590 is being operated. Such a locking mechanism 579 can helpinsure that the medication is delivered without accidentally mixing themedication with a portion of the remaining flush in the first fluidreservoir 516.

After delivering the medication, the transfer device 510 can betransitioned to urge the plunger seal 554 distally to create a createpositive pressure to urge, for example, a second amount of fluid out ofthe first fluid reservoir 516. To move the plunger seal 554 distally,the living hinge 585 can be depressed to decouple the actuator mechanism514 from the housing 512 and second aperture 589. Once the living hinge585 has been disengaged, the plunger seal 554 can be urged distally toempty the remaining fluid from within the first fluid reservoir 516.Delivering a second amount of fluid in a second flush can urge themedication or other fluid administered from the first fluid reservoir516 farther along the attached lumen-defining device (e.g., a CVC line).

The foregoing description of embodiments and examples has been presentedfor purposes of illustration and description. It is not intended to beexhaustive or limiting to the forms described. Numerous modificationsare possible in light of the above teachings. Some of thosemodifications have been discussed, and others will be understood bythose skilled in the art. The embodiments were chosen and described inorder to best illustrate principles of various embodiments as are suitedto particular uses contemplated. The scope is, of course, not limited tothe examples set forth herein, but can be employed in any number ofapplications and equivalent devices by those of ordinary skill in theart. Rather it is hereby intended the scope of the invention to bedefined by the claims appended hereto.

We claim:
 1. A syringe-based apparatus for delivering fluid comprising:(a) a housing, the housing having an open proximal end and a distal enddefining an inner volume; (b) a plunger assembly, the plunger assemblyhaving a proximal end and a distal end, wherein the plunger assembly isretained by the housing; (c) a first fluid reservoir, the first fluidreservoir being defined at least partially by the housing and theplunger assembly, wherein the first fluid reservoir is configured toretain a first amount of a first type of fluid; (d) an actuatormechanism, the actuator mechanism being selectively attachable to theplunger assembly, wherein the actuator mechanism is movable relative tothe housing, the actuator mechanism comprising a syringe body; and (a) aplunger being moveable within the syringe body, the plunger and thesyringe body cooperating to define a second fluid reservoir, wherein thesecond fluid reservoir is configured to retain a second amount of asecond type of fluid; wherein the actuator mechanism is operablyconfigured to transition to a first configuration in which a firstportion of the first amount in the first fluid reservoir is expelled, toa second configuration in which the second amount of the second type offluid in the second fluid reservoir is expelled, to a thirdconfiguration in which a second portion of the first amount in the firstfluid reservoir is expelled.
 2. The apparatus of claim 1, wherein thefirst type of fluid retained by the first fluid reservoir is saline. 3.The apparatus of claim 2, wherein the first amount of the first type offluid is from about 10 ml to about 20 ml of saline.
 4. The apparatus ofclaim 1, wherein the second type of fluid retained by the second fluidreservoir is a medicine.
 5. The apparatus of claim 4, wherein themedicine is epinephrine.
 6. The apparatus of claim 4, wherein themedicine is adenosine.
 7. The apparatus of claim 4, wherein the medicineis valium.
 8. The apparatus of claim 1, wherein the first amount of thefirst type of fluid is user selectable.
 9. The apparatus of claim 1,wherein the first fluid reservoir is selectively detachable from thesecond fluid reservoir.
 10. A syringe-based apparatus for deliveringfluid comprising: (a) a housing defining an inner volume, the housingcomprising a port, the port being positioned at about a distal end ofthe housing; (b) a plunger assembly being moveable relative to thehousing, the plunger assembly comprising a plunger, a plunger seal, anda valve; (c) a first fluid reservoir, the first fluid reservoir beingdefined at least partially by the housing and the plunger seal, whereinthe first fluid reservoir contains a first amount of a first type offluid; (d) an actuator mechanism retained at least partially within theinner volume defined by the housing, the actuator mechanism beingmovable relative to the housing, the actuator mechanism including asyringe body configured to be coupled to the valve; (e) a plungermoveable within the syringe body; (f) a second fluid reservoir, thesecond fluid reservoir being defined at least partially by the syringebody and the plunger, wherein the second fluid reservoir is configuredto retain a second amount of a second type of fluid; and wherein theactuator mechanism is operably configured to transition to a firstconfiguration in which a first portion of the first amount in the firstfluid reservoir is delivered through the port, to a second configurationin which the second amount of the second type of fluid in the secondfluid reservoir is delivered through the port, to a third configurationin which a second portion of the first amount in the first fluidreservoir is delivered through the port.
 11. The apparatus of claim 10,wherein the first type of fluid retained by the first fluid reservoir issaline.
 12. The apparatus of claim 11, wherein the first amount of thefirst type of fluid is from about 10 ml to about 20 ml of saline. 13.The apparatus of claim 10, wherein the second type of fluid retained bythe second fluid reservoir is a medicine.
 14. The apparatus of claim 13,wherein the medicine is epinephrine.
 15. The apparatus of claim 13,wherein the medicine is adenosine.
 16. The apparatus of claim 13,wherein the medicine is valium.
 17. The apparatus of claim 10, whereinthe first fluid reservoir is selectively detachable from the secondfluid reservoir.
 18. The apparatus of claim 10, wherein the first amountin the first fluid reservoir is user selectable.
 19. The apparatus ofclaim 10, further comprising a locking mechanism to selectively couplethe plunger seal and the housing.
 20. A syringe-based apparatus fordelivering fluid comprising: (a) a housing defining an inner volume, thehousing comprising a port, the port being positioned at about a distalend of the housing; (b) a plunger assembly being moveable relative tothe housing, the plunger assembly comprising a plunger, a plunger seal,and a valve; (c) a first fluid reservoir, the first fluid reservoirbeing defined at least partially by the housing and the plunger seal,wherein the first fluid reservoir contains a first amount of fluidcomprising from 10 ml to 20 ml of saline; (d) an actuator mechanismretained at least partially within the inner volume defined by thehousing, the actuator mechanism being movable relative to the housing,the actuator mechanism including a syringe body configured to be coupledto the valve; (e) a plunger moveable within the syringe body; (f) asecond fluid reservoir, the second fluid reservoir being defined atleast partially by the syringe body and the plunger, wherein the secondfluid reservoir is contains a second amount of a medicine; and whereinthe actuator mechanism is operably configured to transition to a firstconfiguration in which a first portion of the first amount of fluid isdelivered through the port, to a second configuration in which thesecond amount of the medicine in the second fluid reservoir is deliveredthrough the port, to a third configuration in which a second portion ofthe first amount of fluid is delivered through the port.